Clinical Trials BC offers regulatory and compliance consulting services for domestic and international trials within BC.
At this time priority is given to ongoing studies with concerns over participant safety and safety reporting. The following are also be considered priorities: maintenance of IP (security, environmental conditions, accounting), label changes, collection of the critical data elements/safety determinants, documentation of deviations from SOPs (planned and unplanned), updates of risk management plans and documentation of protocol deviations (i.e. excursions from visit schedules, in person versus virtual visits).
If you have a question or concern related to clinical trials regulation or compliance we are happy to respond and assist you to navigate to a resource or the appropriate contact person or other services. Please contact Jean Smart for questions, concerns and assistance.